Abstract Number: PB0671
Meeting: ISTH 2021 Congress
Theme: Hemophilia and Rare Bleeding Disorders » Management of Bleeding and Trauma
Background: Hemophilia A and B lead to disability and early need of prosthetic surgery. Extended half-life product (EHL) recently introduced allow to reach higher trough levels with a reduced number of infusions and may allow cost saving in the course of invasive procedures. EHL have demonstrated to be effective and safe for the prevention and treatment of bleeds during major and minor surgery in clinical trials. However, real-world data are still scarce.
Aims: Our aim was to describe our experience with patients with hemophilia A and B treated with extended half-life products for perioperative hemostasis in major orthopedic surgery (LASH study).
Methods: We recruited 10 patients (8 adults, 2 children) affected by hemophilia A (n=7; 6 severe, 1 moderate) and by hemophilia B (n=3; 2 severe, 1 moderate), referring to the Orthopedic Surgery Unit and the Angelo Bianchi Bonomi Hemophilia and Thrombosis Center of Milan to undergo major orthopedic surgery. Informed consent was obtained by participants or their parents and the LASH study was approved by the local ethics committee. Data on perioperatory rFVIII-Fc or rFIX-Fc consumption and pain and satisfaction were collected over a mean follow-up of 11.4 months.
Results: Demographic and clinical characteristics of the patients and details and outcomes of the surgical procedures are reported in table 1. Pain and satisfaction during follow-up are reported in figure 1 A and B.
No thrombotic events were reported and none of the patients experienced inhibitor occurrence during the follow-up.
Median (Interquartile range) | |
Age | 51 (36.5-54.7) years Min-max 8-73 years |
Type of surgery | Ankle 3 total replacement 2 arthrodesis Knee 2 total replacement 1 total replacement revision Other Pseudotumor (hip) Fixation device removal (forearm fracture) |
Hemophilia A preoperative FVIII plasma levels preoperative rFVIII-Fc UI post-infusion FVIII plasma levels post-surgical FVIII plasma levels total perioperative UI consumption total costs of hemostatic treatment (n.UI* 0.62€) |
24% (9%-39%) 63 (50-65) UI/kg 161% (142%-178%) 143% (121%-161%) 22,000 (16,250-36,000) UI 13,640 (10,075-22,320) € |
Hemophilia B preoperative FIX plasma levels preoperative rFIX-Fc UI post-infusion FIX plasma levels post-surgical FVIII plasma levels total perioperative UI consumption total costs of hemostatic treatment (n.UI* 1.01€) |
8% (6%-33%) 53 (46-76) UI/kg 82% (61%-94%) 50% (50%-57%) 34,000 (18,000-49,000) UI 34,340 (18,180-49,490) € |
Length of hospitalisation | 6 (3.25-8.00) days Min-max 1-40 days |
Other perioperative treatments postoperative tranexamic acid thromboprophylaxis |
7 patients 1 patients |
Days of postoperative treatment | 5 (2.5-8) |
Conclusions: In summary, in 10 major orthopedic surgery, rFVIIIFc and rFIXFc demonstrated efficacious hemostasis and a good safety profile, with no inhibitor occurrence and no thrombotic events reported. rFVIIIFc and rFIXFc consumption during major orthopedic surgeries was similar or reduced compared to SHL products. Perioperative pain and satisfaction were acceptable.
Further studies on larger samples and head-to-head studies are needed to confirm our findings.
To cite this abstract in AMA style:
Solimeno LP, Gualtierotti R, Acquati Lozej J, Arcudi S, Biguzzi E, Siboni SM, Carulli C, Peyvandi F. Extended Half-life Products for Perioperative Hemostasis in Major Orthopedic Surgery: Real-world Data from the LASH Study [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/extended-half-life-products-for-perioperative-hemostasis-in-major-orthopedic-surgery-real-world-data-from-the-lash-study/. Accessed March 22, 2024.« Back to ISTH 2021 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/extended-half-life-products-for-perioperative-hemostasis-in-major-orthopedic-surgery-real-world-data-from-the-lash-study/